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FDA Approves Sylatron (peginterferon alfa-2b); Merck

04-Dec-2011

For the treatment of melanoma by Merc; Approved April 2011
 
General Information
Sylatron is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.
Sylatron is specifically indicated for the adjuvant treatment of melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy.
Sylatron is supplied as a powder for reconstitution into a solution designed for subcutaneous administration. The recommended initial dose is 6 mcg/kg/week subcutaneously for eight doses, followed by 3 mcg/kg/week subcutaneously for up to five years. Premedicate with acetaminophen 500 to 1000 mg orally 30 minutes prior to the first dose of Sylatron and as needed for subsequent doses.
 
Side Effects
Adverse events associated with the use of Sylatron may include, but are not limited to, the following:
  • fatigue
  • increased ALT
  • increased AST
  • pyrexia
  • headache
  • anorexia
  • myalgia
  • nausea
  • chills
  • injection site reaction
 
Mechanism of Action
Sylatron is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). Peginterferon alfa-2b is a pleiotropic cytokine; the mechanism by which it exerts its effects in patients with melanoma is unknown.

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